A randomized adjuvant trial of GM2/BCG
A randomized adjuvant trial of GM2/BCG given following surgery for stage III melanoma (AJCC staging) has been conducted in 122 patients at Memorial-Sloan-Kettering Cancer Center (MSKCC) between 1987 and 1988. This trial, reported at more than 5 years of follow-up, has demonstrated the induction of IgM anti-GM2 antibodies in a majority of patients who were immunized, and the presence of native antibodies against GM2 in a small (fewer than 5%) subset of unvaccinated patients in the control group. Antibody response against GM2 was again demonstrated to be a highly significant and favorable prognostic factor. In addition, vaccination was associated with a prolongation of relapse-free survival of borderline statistical significance, confounded by the occurrence of native anti-GM2 antibody responses among six patients in the total, five of whom were entered into the control group. Analysis of the efficacy of immunization among seronegative entrants into this protocol revealed a significant improvement of relapse-free survival associated with GM2/BCG vaccination ( P = .02).
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To further augment the immunogenicity of GM2, a variety of measures have been explored. Covalent attachment of GM2 to carrier proteins, such as keyhole limpet hemocyanin (KLH), has improved the titer and durability of the IgM response seen with BCG and GM2 and induced antibody of the IgG isotype for the first time. A phase-III evaluation of the GM2-KLH vaccine with the QS21 adjuvant has been planned in the ECOG and US Intergroup mechanism, as well as in England.